Jeffery G12016Recalls & reported problems
Cook Incorporated · Jeffery Wire Guide Exchange Set With Nitinol Wire Guide · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002120167), received between Jun 28, 2021 and Dec 5, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Separation” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Separation2
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2022Material Separation; Material Separation
IT WAS REPORTED THE WIRE GUIDE IN A JEFFREY WIRE GUIDE EXCHANGE SET SEPARATED DURING A PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE PROCEDURE. THE WIRE WAS ADVANCED INTO THE PATIENT AND WAS NAVIGATED AROUND A BEND. A COMPETITOR'S DILATOR WAS ADVANCED OVER THE WIRE AND THE WIRE WAS REMOVED. AT THIS TIME, A PORTION OF THE WIRE BROKE AND WAS RETAINED IN THE BILE DUCT. A SAFETY WIRE WAS THEN ADVANCED TO MAINTAIN ACCESS TO THE BILE DUCT AND THE WIRE FRAGMENT WAS RETRIEVED USING A SNARE. THE PROCEDURE WAS COMPLETED WITH A NEW WIRE GUIDE. IT WAS NOTED THAT THE PROCEDURE WAS PROLONGED DUE TO THIS INCIDENT. NO OTHER ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15920900 ↗InjuryJun 28, 2021Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Foreign Body In Patient
MAUDE report 12076031 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.